# FDA 483 - PTC Therapeutics, Inc. - November 18, 2024

Source: https://www.globalkeysolutions.net/records/483/ptc-therapeutics-inc/8e4bd065-ca6a-4b5f-8e04-81589b640e0e

> FDA 483 for PTC Therapeutics, Inc. on November 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PTC Therapeutics, Inc.
- Inspection Date: 2024-11-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of PTC Therapeutics, Inc. in Warren, NJ, revealed a failure to ensure proper monitoring of a clinical study. Specifically, site monitoring did not adequately identify and document discrepancies in investigational product accountability as protocol deviations for non-compliant subjects. This indicates issues with clinical trial oversight and data integrity.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/ptc-therapeutics-inc/821471cd-a638-4ee7-b662-ab8ad343be75)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.globalkeysolutions.net/companies/ptc-therapeutics-inc/7121dadc-2bde-46a2-bf7f-1b7b40da4b6d

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248